Tanım
E.coli Host Cell RNA Residue Detection Kit is used for the quantitative analysis of E.coli host cell RNA residuce in intermediate samples, semi-finished and finished products of various biological products.
This kit adopts Taqman fluorescent probe and the polymerase chain reaction (PCR) method, which has fg level minimum detection limit and can specifically and quickly detect the residual E.coli cell RNA. The kit needs to be used together with the the Residual DNA Sample Preparation Kit (Cat# 18461ES) and Recombinant DNase I (RNase-free, Yeast) (Cat#14534ES50/14534ES60).
Feature
- Compliance with regulations: the products are fully validated according to the requirements of Chp, USP, ICH, etc., and their performance is in line with Chinese and foreign regulations and standards;
- Guarantee of quality: the raw materials of the kits are all self-developed, and the qPCR Mix and other enzyme products are produced in an ultra-clean enzyme factory;
- High sensitivity: the limit of quantification can reach 1 fg/μL level;
- High precision: high intra-batch repeatability and low inter-batch variation;
- Strong exclusivity: specific detection of residual RNA in E.coli cells without interference from other exogenous genomic DNA and RNA;
- Strong anti-interference: add internal control (IC), easy to exclude sample interference, reaction preparation abnormalities and other factors.
Application
- Residual E.coli Host Cell RNA test in biological products.
Specification
Sensitivity |
1 fg/μL (range 2fg/μL~200pg/μL) |
Assay Time |
~1.5 hours |
Assay Principle |
Fluorescent probe qPCR method |
Required Instruments |
Real-time fluorescence quantitative PCR system |
Components
Components No. |
Name |
41318ES50-EN |
41318ES60-EN |
41318-A |
E.coli qPCR Mix |
0.75 mL |
1.5 mL |
41318-B |
One Step Enzyme Mix |
200 μL |
400 μL |
41318-C |
RNA Dilution Buffer |
1.8 mL×2 |
1.8 mL×4 |
41318-D |
E.coli RNA Control(20 ng/μL) |
25 μL |
50 μL |
41318-E |
IC* |
50 μL |
100 μL |
*IC:Internal control.
Storage
This product should be stored at -25~-15℃ for 2 years.
Both 41318-A should be stored protected from light.
Figures
- Limit of quantification
E.coli RNA was detected at 5 fg/uL, 2 fg/uL, and 1 fg/uL, with 10 replicates for each concentration. The results showed that the CV was <20% at concentrations of 1 fg/uL and above, i.e., the limit of quantification of the E.coli host cell RNA residue detection kit was 1 fg/uL.
Table 1. Limit of quantification (LOQ) assay results for E.coli RNA
Repetition number Test item |
E.coli RNA (fg/uL) |
|
Quantity |
Return ratio |
|
1 |
0.98 |
98% |
2 |
1.00 |
100% |
3 |
1.37 |
137% |
4 |
0.97 |
97% |
5 |
0.97 |
97% |
6 |
1.02 |
102% |
7 |
0.98 |
98% |
8 |
1.06 |
106% |
9 |
1.08 |
108% |
10 |
1.03 |
103% |
Average value |
1.05 |
\ |
CV% |
11.44% |
\ |
Documents:
Safety Data Sheet
Manuals
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